EMRI SureScan™ Clinical Study

Bradycardia Clinical Trial

Official title:

EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433654
• Other study ID #: 212
• Status: Completed
• Phase: N/A
• First received: February 2, 2007
• Last updated: October 17, 2011
• Start date: February 2007
• Est. completion date: August 2010

Study information

• Verified date: July 2011
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationAustria: Federal bureau for security in public healthBelgium: Ministry of Social Affairs, Public Health and the EnvironmentGermany: Bezirksregierung DusseldorfItaly: Ministry of HealthNetherlands: Federal Ministry of Social Affairs, public health and Environment Service Medical AidsSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

Description:

This study is a prospective, multi-center global study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: August 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.

• Subject available for follow-up at study center for length of study.

• Subject able and willing to undergo elective MRI scanning without sedation.

Exclusion Criteria:

• Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).

• Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.

• Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.

• Subject with exclusion criteria required by local law.

• Subject who intends to participate in another clinical study during this clinical study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bradycardia
• Slow Heart Beat

Intervention

Device:
• Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Pacer and leads

Other:
• Magnetic Resonance Imaging (MRI) scan
One hour MRI scan on the head and lower back.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging (MRI)-Related Complications	Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.	MRI scan to one-month post-MRI scan	No
Primary	Atrial Pacing Capture Threshold Success	Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.	9-12 week visit to 4-month visit	No
Primary	Ventricular Pacing Capture Threshold Success	Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.	9-12 week visit to 4-month visit	No
Primary	Atrial Sensed Amplitude Success	Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).	9-12 week visit to 4-month visit	No
Primary	Ventricular Sensed Amplitude Success	Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).	9-12 week visit to 4-month visit	No
Secondary	Subjects With System-related Complications	Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.	Implant to 4 Months	No
Secondary	System Related Adverse Device Effects Due to Labeling Instructions	Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.	Implant through 18 months post-implant	No
Secondary	Occurrence of Arrhythmias	Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan	During the MRI scan	No
Secondary	Atrial Lead Impedance Change	Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.	9-12 week visit and 4-month visit	No
Secondary	Ventricular Lead Impedance Change	Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.	9-12 week visit and 4-month visit	No
Secondary	Atrial Lead Handling Rating	Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.	During implant	No
Secondary	Ventricular Lead Handling Rating	Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.	During implant	No
Secondary	Atrial Pacing Capture Threshold	Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.	3 or 4 months post-implant	No
Secondary	Ventricular Pacing Capture Threshold	Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.	3 or 4 months post-implant	No
Secondary	Atrial Sensed Amplitude	Average atrial sensed amplitude.	3 or 4 months post-implant	No
Secondary	Ventricular Sensed Amplitude	Average ventricular sensed amplitude.	3 or 4 months post-implant	No